Status:
COMPLETED
Neoadjuvant Chemoradiotherapy With Sequential Ipilimumab and Nivolumab in Rectal Cancer
Lead Sponsor:
Johannes Laengle, MD, PhD
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief Summary
This prospective randomized, open-label, multicenter, phase II clinical trial investigates the safety and tolerability of standard neoadjuvant chemoradiotherapy (CRT) with sequential ipilimumab and ni...
Eligibility Criteria
Inclusion
- 18 years of age and older
- All sexes
- Histologically confirmed carcinoma of the rectum
- Suitable for local therapy with curative intent
- Medical need for a standard neoadjuvant CRT
- Suitable to withstand a course of standard neoadjuvant CRT
- Written informed consent form (ICF) for participation in the study
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion
- Metastatic disease that is considered incurable by local therapies
- Previous surgery of the tumor other than biopsy
- Pregnancy, breastfeeding or expectancy to conceive
- Disagreement of participants with reproductive potential to use contraception throughout the study period and for up to 180 days after the last dose of study therapy
- Prior therapy with anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2 or any other agent directed against co-inhibitory T cell receptors or has previously participated in clinical studies with immunotherapy
- Any contraindication according to the official medical information of Ipilimumab or Nivolumab
- Live vaccine within 30 days prior to the first dose of study therapy
- Hepatitis B or C
- Human immunodeficiency virus (HIV)
- Immunodeficiency
- Allogeneic tissue or solid organ transplantation
- Autoimmune disease that has required systemic therapy in the past 2 years with modifying agents, steroids or immunosuppressive drugs
- Systemic steroids or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
- Active non-infectious pneumonitis
- Active infection requiring systemic therapy
- Treatment with botanical preparations (i.e. herbal supplements or traditional Chinese medicines) intended for general health support or to treat the disease under study within 2 weeks prior to randomization/treatment
- Participants with serious or uncontrolled medical disorders
- Uncontrolled or significant cardiovascular disease (myocardial infarction, uncontrolled angina, any history of clinically significant arrhythmias, QTc prolongation in males \> 450 ms and \> 470 ms in females, participants with history of myocarditis)
- Allergies and adverse drug reaction (history of allergy or hypersensitivity to study drug components, contraindications to any of the study drugs of the chemotherapy regimen)
- Other exclusion criteria: Prisoners or participants who are involuntarily incarcerated, participants who are compulsorily detained for treatment of either a psychiatric or physical (i.e. infectious disease) illness
- White blood cells \< 2000/μL (SI: \< 2.00 × 109/L)
- Neutrophils \< 1500/μL (SI: \< 1.50 × 109/L)
- Platelets \< 100 × 103/μL (SI: \< 100 × 109/L) (transfusions not permitted within 72 h prior to qualifying laboratory value)
- Hemoglobin \< 9.0 g/dl (SI: \< 90 g/L) (transfusions not permitted within 72 h prior to qualifying laboratory value)
- Serum creatinine \> 1.5 × upper limit of normal (ULN) or calculated creatinine clearance \< 50 ml/min (using the Cockcroft-Gault formula)
- AST/ALT: \> 3.0 × ULN
- Total bilirubin \> 1.5 × ULN (except participants with Gilbert Syndrome who must have a total bilirubin level of \< 3.0 × ULN)
- Troponin T (TnT) or I (TnI) \> 2 × institutional ULN. TnT or TnI levels between \> 1 to 2 × ULN will be permitted to participate in the study if a repeat assessment remains 2 × ULN and participant undergoes a cardiac evaluation. When repeat levels within 24 h are not available, a repeat test should be conducted as soon as possible.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04124601
Start Date
June 1 2020
End Date
March 15 2024
Last Update
April 23 2024
Active Locations (5)
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1
State Hospital Wiener Neustadt
Wiener Neustadt, Lower Austria, Austria
2
Congregational Hospital Linz - Sisters of Mercy
Linz, Austria, 4010
3
Hospital of St. John of God
Vienna, Austria, 1020
4
Medical University of Vienna
Vienna, Austria, 1090